Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs

Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.

GUEST COLUMNISTS

Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

PHARMA OUTSOURCING WHITE PAPERS

SEDDS: Improving Oral Bioavailability Of Poorly Soluble Compounds
Nearly 90% of marketed drugs have poor water solubility. Learn how self-emulsifying drug delivery systems (SEDDS) resolve oral bioavailability failures across BCS Class II and IV compounds.

Nucleic Acid-LNP Ultrafiltration And Diafiltration
Downstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.
Innovations In API Manufacturing Of Small Molecule Drugs
Read how advances in people, processes, technology, materials, analytics, and sustainability are reshaping small‑molecule API manufacturing to reduce costs, scale efficiently, and meet future demand.
Spray Dry Biologics For Oral Dosage Forms
Spray drying enables stable oral delivery of biologics by creating protective dry powders, improving bioavailability, stability, and targeted release compared with traditional formulation methods.
GLP-1 Peptides Around The World
Explore how evolving regulations, supply constraints, and reimbursement models shape GLP-1 drug development across the U.S., Europe, and Asia.
Validating Tubing For Closed-System Bioprocessing
Uncover how advanced tubing materials improve weld integrity, reduce particulates, and support sterilization compatibility for closed-system bioprocessing.